RECRUITING

Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use. Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.

Official Title

Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use

Quick Facts

Study Start:2025-09-15
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06991205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Outpatient adults seeking care in the Hand and Arm Center
  2. 2. Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
  3. 3. Pain score \> 4 on the Numerical Rating Scale (NRS)
  4. 4. Risky substance use (scores \>10 and \<27 for alcohol, and \>3 and \<27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette on The World Health Organization's - Alcohol, Smoking and Substance Involvement Screening Test \[WHO-ASSIST\])
  5. 5. Owns a smartphone, laptop, or computer with internet access
  6. 6. Age ≥18yr
  7. 7. English fluency
  8. 8. Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention
  1. 1. Participation in mind-body or specialized substance abuse treatment in the past 3 months
  2. 2. Practice of mindfulness \>45 minutes/week in the past 3 months
  3. 3. Psychotropic medications (e.g. antidepressants) changed in the past 3 months
  4. 4. Serious untreated mental illness (e.g., Schizophrenia)
  5. 5. Suicidal ideation with intent or plan
  6. 6. Pregnancy
  7. 7. Secondary gains that may bias motivation (e.g., pending disability claim),
  8. 8. Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
  9. 9. History of surgery for the presented NPUC within the past 6 months OR future plans for surgery.

Contacts and Locations

Study Contact

Jafar Bakhshaie, MD, PhD
CONTACT
617-643-7641
jbakhshaie@mgh.harvard.edu
Nadine Levey, BA
CONTACT
617-724-8431
nlevey@mgh.harvard.edu

Principal Investigator

Jafar Bakhshaie, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Jafar Bakhshaie

  • Jafar Bakhshaie, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-15
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2025-09-15
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Upper Extremity Problem
  • Risky substance use
  • Randomized Controlled Trial (RCT)
  • Mindfulness
  • Nontraumatic conditions
  • Chronic pain
  • Psychiatry
  • Feasibility

Additional Relevant MeSH Terms

  • Orthopedic Disorder
  • Nontraumatic Injury
  • Upper Extremity Pain
  • Risky Substance Use